The invention relates to a percutaneous implant for implantation into an animal or a human body.
A method for implantation of the implant according to the present invention into an animal or a human body is also described together with preferred uses.
The implant is of the kind comprising an axial interior section for fixation inside the body, an axial exterior section in communication with the interior section, said axial exterior section extending outwards from the body with a free end, which serves for mounting of a detachable device, the distal end of the interior section opposite the exterior section being provided with an subcutaneous anchoring section, extending radially from the distal end of the interior section.
Many diseases such as e.g., Crohn's disease, ulcerative colitis, intestinal cancer and adenomatous polyposis or bladder cancer require removal of all or part of the intestines or bladder. When the intestines or the bladder are removed, the bodily wastes are expelled through a new surgical opening in the abdominal wall. The surgery to create the new opening, the stoma, is called ostomy. The main steps in the surgery are to create an abdominal opening, to externalize an intestine through the abdominal wall and skin, and suture the intestine to the skin so as to complete the stoma.
The prior art types of intestinal ostomies are performed depending on how much and what parts of the intestines are removed. The surgery is called an ileostomy if the colon and rectum are removed, in which case an ileostomy is performed by attaching the ileum to the stoma. If the rectum is removed, the colon is attached to the stoma to perform a colostomy. Most persons with ostomies must wear special appliances over the stoma and use ostomy pouches to collect and eliminate waste.
A continent ileostomy is the most preferred alternative to using an outside collecting bag. An internal reservoir pouch is created from part of the small intestine. A valve is constructed and a stoma is placed through the abdominal wall. A tube must be inserted through the stoma and the valve in order to drain the pouch from time to time. The most common kind of continent ileoanal reservoir has a capacity of 500 to 1000 mL and a valve made by intussusception of the terminal ileum.
Only for very few patients, ileoanal reservoir surgery is a possible alternative to a permanent ileostomy. Ileoanal reservoir surgery is completed in two surgeries. In the first surgery, the colon and rectum are removed and a pouch or reservoir is constructed from the last part of the small intestine. This pouch is attached to the anus. In the second surgery, the ileostomy is closed. The muscles surrounding the anus and anal canal are left in place, so the stool in the pouch does not leak out of the anus.
Different kinds of urostomy surgery are used dependent on the disease causing the surgery. Usually the ureters are detached from the bladder and joined to a section of the ileum to create an ileal conduit for the urine. One end of this section of ileum is sealed off and the other end is brought to the surface of the abdomen to the stoma to allow urine to be collected in a urine pouch attached around the stoma.
Alternatively, an uretero-cutaneostomy is possible in which the ureters are detached from the bladder and brought to the surface of the abdomen. A uretero-cutaneostomy can be made as a “single” uretero-cutaneostomy in which only one ureter is brought to the surface, a “bilateral” uretero-cutaneostomy with one ureter in each side of the abdomen, a “double-barrel” uretero-cutaneostomy in which both ureters are brought to the same side of the abdomen but externalized using two holes, or a “transuretero” uretero-cutaneostomy in which both ureters are brought to the same side of the abdomen and externalized via one common hole.
The above-mentioned methods are drastic surgical procedures of great discomfort to the patient both before and after surgery is completed.
In summary there are several drawbacks with the above conventional methods including ulceration, incisional hernia, or bulging of the bowel through the incision, narrowing of the stoma, scar tissue and bowel obstruction, marsupialization, avulsion, skin irritation from stool that leaks under the drainage bag and necrosis.
In addition, use of a stoma pouch for collection of the bodily wastes must be used for most ostomies. The stoma pouch is conventionally adhered to the skin by means of an adhesive contact surface on the pouch so as to allow the pouch to surround the stoma for sealingly collecting stool or urine. If liquid secretion penetrates the adhesive surface, this surface will loosen to a certain extent, resulting in leakage from the pouch and the release of an unpleasant smell.
Another problem with ostomies is that the site where the intestine passes the abdominal wall is weak and susceptible to herniation. Hernias result in blockage of the stoma and relief surgery is urgently required.
A number of implants have been provided in order to remedy the above-named disadvantages of the above mentioned prior art systems available today for patients having a stomy.
U.S. Pat. No. 4,183,357 discloses a transcutaneous implant for use with enterostomies. The implant consists of a hollow barrel with a protruding flange, which is permanently positioned under the skin between the dermis and the fascia. The intestine is externalized by drawing the intestine up through the barrel. The barrel surrounds and supports the stoma, however the rigid wall of the implant critically restricts the peristaltic movements.
Similar implant devices for surrounding an enterostomy are disclosed in U.S. Pat. No. 4,217,664 and GB patent No. 2 019 219.
International patent application WO 98/58691 discloses an implant to be used in an intraluminal procedure. A hole is prepared with a purse string suture in the terminated proximal sigmoideum. The plane contact face of the implant is introduced via a colostomy aperture in the abdominal wall and fitted into the prepared aperture in the sigmoideum. The purse string suture is secured and the sigmoideum wall is brought into contact and attached to the parienteral peritoneum surrounding the exterior surface of the implant, the flange part of which is left inside the sigmoideum. The extent of the anchoring zone between the sigmoideum, the peritoneum and the flange is minimal so that fluctuating tensile forces and compressions resulting from peristaltic movements are not restricted. Use of this device involves a high risk of total or partial rupture between tissue and implant, e.g. in case of high back pressure resulting from constipation. Urine or stool may leak and cause inflammation and peritonitis. Thus, improvements in these type devices are desired.